We have a vacancy for a Clinical Lead Vendor Oversight and a Medical Writer
Blueberry’s vision is to bring high value, innovative medicines to the market that make a real difference to patients’ lives. We are now growing, and looking for a full time Clinical Lead Vendor Oversight and a Medical Writer to join our successful team. If you have the skills listed below, enjoy working in a dynamic, exciting environment, and really want to have a positive impact on patients’ lives, then we’d love to hear from you.
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Clinical Lead Vendor Oversight
The Clinical Lead Vendor Oversight will ensure adequate scientific support for Company clinical development programmes, providing expert input into clinical studies, clinical strategy, implementation of the Clinical Development Plan, as well as participation in problem-solving initiatives within development projects.
He or she will work under limited supervision to develop solutions utilising creativity and ingenuity, represent the organisation as a prime contact for technical matters and manage responsibility under a no cost centre budget.
Tasks & Responsibilities:
- Set objectives, deliver results and implement policies and operational targets that have a direct impact on the work unit or operational outcome
- Develop clinical trial designs, protocols and the clinical aspects of the execution of clinical trials Phases I-IV
- Develop suitable clinical development plans (and clinical section of Drug Development Plans) to address the global development requirements of the Company
- Key member of the regulatory document preparation and review team
- Key contributor in the review and interpretation of clinical trials data and development of associated integrated analyses and label claims.
- Stay updated on competitors and changes in the relevant therapeutic areas as appropriate
- Represent Company at professional meetings and with regulatory authorities as required
- Interact with KOLs across the relevant therapeutic areas as appropriate.
- May lead agendas and presentations to Executive level meetings and support Advisory Board meetings as required
- Work closely with Finance team to ensure transparency of Clinical plans and ensure sensitivity to overall company budgets.
- May manage the activities of contractors and ensure that contractors, consultants and vendors complete assigned project work according to agreed timelines. This may include troubleshooting routine client inquiries.
- Degree in relevant scientific subject e.g., biochemistry, pharmacology.
- Minimum 10+ years’ industry experience in Clinical, Regulatory or Medical functional areas and at a Program level for some of that time
- Up to date GCP training (within last 2 years)
- Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
- Strong team player
This role was posted on 20th August 2019.
To apply for this role, please email your CV and covering letter to Susie Yau, Office Manager: email@example.com by Friday 27th September 2019.
As a Medical Writer, you will be familiar with documents such as clinical study reports and the common technical document (CTD), and will be able to evaluate scientific data objectively, in order to report results and scientific concepts in a concise and accurate manner. In addition, you will work closely with the Clinical team and Regulatory Affairs Director to lead the planning and delivery of regulatory submissions and other projects.
Tasks & Responsibilities:
- Preparation, editing, formatting and finalisation of the following documents:
- Clinical documents; such as Protocol, Protocol Amendment, ICF, PIS, IB, CSR
- Regulatory documents; such as IND, NDA (ISS/ISE), Briefing documents
- Safety documents; such as DSUR, PSUR, ASR, Case Narratives
- Scientific Publications; such as Manuscripts, Abstracts, White Papers
- Manage medical writing timelines with functional area timelines for assigned documents to ensure on-time deliverables.
- Communicate with document authors, owners, contributors, and reviewers of different functional areas internally and externally to ensure appropriate coordination of and input into medical writing tasks.
- Facilitate comment resolution with authors, reviewers, and project teams.
- Participate in the development of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables.
- Assist in the interviewing, mentoring, and integration of new staff.
- Build and manage external relationships in support of these tasks as appropriate.
- Minimum of 3-5 years Medical Writing experience at a lead author level in the following; Clinical documents, Regulatory documents, Safety documents, Scientific publications.
- Strong scientific background including a minimum of a BSc (or equivalent) in an appropriate scientific discipline.
- Familiarity with EU regulatory guidelines for document development with respect to structure, format, and content. Having this experience in the US would be an advantage.
- Excellent writing skills with comprehensive knowledge of drug development process and applicable regulatory guidelines.
- Excellent written and spoken English, and a good working understanding of clinical development and ICH guidelines for regulatory documents.
- Proven track record of working on drug development programmes from pre-clinical and early phase clinical through to marketing application.
- Proactive, well-developed project management skills, and confident and effective interpersonal skills.
- Flexibility for occasional travel within Europe.
- A strong team player with the flexibility and the willingness to get involved with other activities that support the development of our drug programs.
To apply for this role, please email your CV and covering letter to Susie Yau, Office Manager: firstname.lastname@example.org by Friday 23rd August 2019.